ISO 11615 Authorised Medicinal Product

This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)

The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)

If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)

If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)

This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)

The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)

9.2.2.11

The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)

The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)

The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)

The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)

This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)

This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)

This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)

9.9.2.3

The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)

The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)

The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)

The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)

9.9.2.6

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

9.9.2.5

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

9.9.2.2

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

9.9.2.6

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

9.9.2.5

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

9.9.2.4

The text of the undesirable effect shall be given. (9.9.2.4.2)

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

9.9.2.5

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

9.2.2.10

This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)

The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)

This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)

This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)

9.9.2.7

The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)

This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)

The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)

The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)

The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)

The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)

9.5.2.2

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.5.2.3

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

9.3.2.5

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.3.2.2

The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)

The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)

The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)

The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)

The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)

The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)

The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)

The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)

The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)

The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)

This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)

9.3.2.10

This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)

This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)

The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)

The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)

9.3.2.3

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.3.2.4

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

This is the date when the SME status was granted. (9.3.2.4.4)

9.3.2.6

The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)

The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)

The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)

The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)

9.3.2.7

A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)

The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)

The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)

9.3.2.5

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.3.2.9

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

9.3.2.8

The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)

Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)

This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)

The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)

The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)

Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)

Any additional comment on supply shortage. (9.3.2.8.8)

9.3.2.9

The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)

Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)

The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)

Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)

The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)

The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)

Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)

The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)

The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)

9.2.2.5

This attribute is to define which kind of master file is indicated (9.2.2.5.2)

This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)

9.2.2.6

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.2.2.8

The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)

The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)

The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)

The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)

The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)

The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)

The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)

The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)

The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)

The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)

The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)

The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)

The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)

A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)

9.2.2.9

The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)

The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)

The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)

9.2.2.3

This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)

This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)

This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)

This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)

This field is to indicate the orphan designation decision number. (9.2.2.3.6)

9.6.2.2

This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)

A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)

9.6.2.8

The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)

The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)

This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)

9.5.2.2

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.5.2.3

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

9.3.2.5

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.3.2.2

The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)

The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)

The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)